In the EHDEN project, sustainability and outreach were inherent in its design in Work Package 6 (WP6) right from the very beginning, which differentiated it from many other IMI projects. We always considered EHDEN to be a start-up within IMI with a post-project future, rather than having a project mentality with a start, middle and end.
One of the basic requirements for a sustainable future of any project/start-up is that the customers and users are happy – and that it delivers against its goals. Thus, WP6 members worked on the development of tailored value propositions (VPs) for Pharma/Biotech/Medical Device companies, CROs, Academia, HTAs/Regulators, Patient Advocacy Groups, Data Partners and SMEs. One must ask if these VPs were truly covering the desired values for the respective groups? To not leave this to speculation, we also carried out a survey for the VPs of the EHDEN Data Partners and SMEs and both had responded – essentially confirming that the VPs met their needs.
We also looked at the motivation for Data Partners in applying to EHDEN, and above financial interest, if they were able to participate in collaborative studies, promote their own data and be part of an international network were priorities.
Similarly, WP6 created a survey for pharma companies assessing their needs and their pain points. The survey very much confirmed the expectation of EHDEN and the project’s ultimate target, i.e., also contributing to a likely successful transition from a project into a sustainable organisation.
Much thought was given to the question as to whether the future of the EHDEN successor organisation should be set up with a relaxed approach, which should be managed to a certain extent, but not focus too much on the nitty gritty details or whether it should be a strictly controlled, tightly managed organisation. The recommended approach is to follow the partially controlled, but rather flexible set up of the post-EHDEN organisation.
In order to ultimately support sustainability, WP6 also started developing various VPs. These will be used to create the not-for-profit organisation on one hand, but also to help nurture the future development of additional aspects related to real world data and real- world evidence. Further work on the operating model for the future, linked to the study workflow, and study and research programme coordination, will be an imperative in the remaining time of the IMI project.
Surprisingly – at least for some – the ‘outreach’ aspect had not been as challenging as originally anticipated. Based on an overwhelming response from a series of open calls, Data Partners and SMEs were obviously very interested in joining EHDEN and contributing their data and expertise to the project. To date, the EHDEN network has grown to 140 Data Partners in 16 countries and 47 SMEs in 19 countries across Europe, which is set to soon expand even further.
In essence, all WP6 colleagues are very optimistic with respect to a positive outcome of the sustainability activities in EHDEN. What, however, will the situation be like in a year or two after the completion of the project? What would we or the outside world view as a ‘success’ of EHDEN’s activities? Preferably, the not-for-profit organisation will be able to support data visiting to a substantial number of anonymous patient records, will be able to add new Data Partners, will create an environment that more entities want to join and ultimately, support the rapid delivery of real world evidence analyses that lead to improved patient outcomes, which is EHDEN’s overarching goal!
Bayer Senior Expert, on behalf of EHDEN WP6